The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Attune™ total Knee System.
| Device ID | K201347 |
| 510k Number | K201347 |
| Device Name: | DePuy ATTUNE™ Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| Applicant | DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Contact | Karen Mahoney |
| Correspondent | Mary Wood DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | OIY |
| Subsequent Product Code | JWH |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-21 |
| Decision Date | 2020-06-18 |